Class III
Terminated
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
This recall has been terminated (originally issued April 13, 2016).
- Company
- Bio-Pharm, Inc.
- Recall Initiated
- December 17, 2015
- Posted
- April 13, 2016
- Recall Number
- D-0809-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 103,664 Bottles
- Firm Location
- Levittown, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017
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